Staff Process Engineer/ Quality Systems Engineer - Remote

Overview

Staff Process Engineer / Quality Systems Engineer - Remote

Location: San Diego, CA

Duration: 12 Months • Total Hours/week: 40 • 1st Shift

Client: Medical Devices Company • Job Category: Professional • Level of Experience: Senior Level • Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, or CPT eligible)

Note: This is a hybrid position. Remote work may be considered on a case-by-case basis.

Responsibilities

• Define and implement software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry.
• Lead software process definition and remediation of design documentation to ensure end-to-end traceability and compliance with regulatory requirements (e.g., FDA guidance, IEC 62304, IEEE standards).
• Remediate design control documentation for accuracy, completeness, and clear upstream/downstream traceability from software-centric design control elements.
• Lead continuous improvement efforts, collaborate with multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.
• Translate business and regulatory requirements into comprehensive software development processes; communicate status and concepts to stakeholders at varying levels of technical ability.
• Facilitate cross-functional collaboration across Systems, Hardware, Test, Quality, and other departments to resolve alignment or feasibility issues.
• Apply best practices from methodologies such as DFSS and Critical Parameter Management to projects; review and remediate software design control documentation.

Key Responsibilities

• Software Process Definition: Develop and implement software processes that comply with industry standards and regulations (e.g., IEC 62304, FDA guidance, IEEE standards) across the full software development lifecycle.
• Software Design Documentation Remediation: Create or modify software design documentation templates within the Quality Management System; ensure end-to-end traceability and remediate gaps and errors as needed.
• Leadership: Transform regulatory requirements into comprehensive software development processes; maintain clear communication with team members and leaders; identify risks and implement mitigations.
• Cross-Functional Collaboration: Enable knowledge sharing across departments to resolve alignment or feasibility issues; communicate project status and design details to stakeholders.
• Continuous Improvement: Identify opportunities to improve software engineering processes for efficiency, quality, and compliance.
• Technical Expertise: Provide guidance on process and documentation; apply DFSS and related practices to projects; review and remediate software design control documentation.

Minimum Qualifications

Education & Experience

• Bachelor’s degree in Science or Engineering required; postgraduate degree preferred
• Minimum 5 years of related work experience in software engineering, medical device development, or similar; experience with regulatory standards (IEC 62304, FDA guidance, IEEE) in a regulated industry highly preferred
• Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader
• Positive attitude with critical thinking; willingness to learn and adapt
• Strong organizational skills; ability to work independently and in a team; ability to handle multiple tasks and prioritize

Technical Skills

• Strong background in software engineering, testing, and requirements management
• Experience in software product development: needs assessment, system analysis, architectural design, integration and testing, reliability engineering, project management, and FMEA
• Experience creating and maintaining design and development documentation; knowledge of DFSS or statistical test design is preferred
• Experience in Quality engineering and design control management is a plus
• Experience with ALM/PLM tools is a plus
• Excellent communication skills and attention to detail; ability to work in an agile environment is a plus
• Must be legally authorized to work in the United States without sponsorship now or in the future

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